Effects of alpha lipoic acid on ß- Thalassemia Major

Evaluation of the effects of alpha lipoic acid or placebo on lipid profile, oxidative stress and iron overload in patients with ß-thalassemia major.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017061714237N2

Enrollment

Registered

2017-08-15

Start date

2017-09-23

Completion date

Unknown

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ß-thalassemia Major. Beta thalassaemia

Interventions

Intervention 1: Intervention group: 600 mg alpha lipoic acid (C8H14O2S2) capsules once a day for 8 weeks. Product of Support Nutrition company, USA. Intervention 2: Control group: 600 mg placebo capsu

Eligibility

Sex/Gender

All

Age

15 Years to 30 Years

Inclusion criteria

Inclusion criteria: Age over 15 years

Exclusion criteria

Exclusion criteria: History of hepatitis B and C heart failure and kidney failure cancer allergies digestive problems disrupting drug intake pregnancy smoking The use of shlaturi except Desphonac following a particular diet

Design outcomes

Primary

Measure	Time frame
Homocysteine (HCY). Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: µmol/L, ELIZA.;Lipoprotein-associated phospholipase A2 (Lp-PLA2). Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: nmol/mL, ELIZA.;Trimethylamine N-oxide (TMAO). Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: µmol/L, ELIZA.;Osteoprotegerin (OPG). Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, ELIZA.;Total antioxidant capacity. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: nmol/ml, ELIZA.;Malondialdehyde. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: nm/ml, Tiobarbitoric acid.;Serum Iron. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: µmol/ml, photometric.;Ferritin. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: ngram/ml, ELIAZ.;Transferrin. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: µgram/ml, ELIZA.	—

Measure

Time frame

Homocysteine (HCY). Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: µmol/L, ELIZA.;Lipoprotein-associated phospholipase A2 (Lp-PLA2). Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: nmol/mL, ELIZA.;Trimethylamine N-oxide (TMAO). Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: µmol/L, ELIZA.;Osteoprotegerin (OPG). Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, ELIZA.;Total antioxidant capacity. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: nmol/ml, ELIZA.;Malondialdehyde. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: nm/ml, Tiobarbitoric acid.;Serum Iron. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: µmol/ml, photometric.;Ferritin. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: ngram/ml, ELIAZ.;Transferrin. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: µgram/ml, ELIZA.

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Secondary

Measure	Time frame
Serum Triacylglyceride. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, Enzymatic.;Serum Cholesterol. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, Enzymatic.;HDL-c. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, Direct Enzymatic.;LDL-c. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, FriedWald Formula.;Body Weight. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: Scale, Kilogram.	—

Measure

Time frame

Serum Triacylglyceride. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, Enzymatic.;Serum Cholesterol. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, Enzymatic.;HDL-c. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, Direct Enzymatic.;LDL-c. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: mg/dl, FriedWald Formula.;Body Weight. Timepoint: Week 0, Week 8, Week 11, Week 19. Method of measurement: Scale, Kilogram.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Abdollahzad

Kermanshah University of Medical Sciences

Hadi_Nut@yahoo.com+98 83 3826 2052

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026